A Double-blind, Randomized, Placebo-controlled, Single-ascending Dose Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) Following Intramuscular Administration in Healthy Volunteers

Daewoong Pharmaceutical Co. LTD.0 sites24 target enrollmentOctober 19, 2020

ConditionsCOVID-19 Patients

InterventionsDWRX2003

DrugsDWRX2003

Overview

Phase: Phase 1
Intervention: DWRX2003
Conditions: COVID-19 Patients
Sponsor: Daewoong Pharmaceutical Co. LTD.
Enrollment: 24
Primary Endpoint: Incidence of Treatment-Emergent Adverse Events
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This study is designed to assess the safety, tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) in healthy volunteers.

Registry

clinicaltrials.gov

Start Date

October 19, 2020

End Date

June 30, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Daewoong Pharmaceutical Co. LTD.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy males and females, between 18 and 65 years of age, inclusive, at time of signing the Informed Consent Form (ICF).
•Body mass index between 18.0 lesser than or equal to Body Mass Index (BMI) lesser than or equal to 32 at Screening, with a minimum weight of 50 kg (inclusive).
•Willing to sign ICF on a voluntary basis and to voluntarily participate in the study, after being fully informed of and completely understanding this study, prior to any Screening procedure being undertaken

Exclusion Criteria

•Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period;
•History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). Please note participants with allergies which can be managed without treatment can be included based on the decision of the Investigator (or designee).
•Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee)

Arms & Interventions

Cohort 1 (288mg)

72 mg/0.3 mL x 4 injection sites

Intervention: DWRX2003

Cohort 2 (576 mg)

144 mg/0.6 mL x 4 injection sites

Intervention: DWRX2003

Cohort 3 (960 mg)

216 mg/1.0 mL x 4 injection sites

Intervention: DWRX2003

Outcomes

Primary Outcomes

Incidence of Treatment-Emergent Adverse Events

Time Frame: follow-up 35 days after dosing

Incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs)

Secondary Outcomes

To assess PK parameters of niclosamide injectable (DWRX2003) through tmax(at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28)
To assess PK parameters of niclosamide injectable (DWRX2003) through AUC0-∞(at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28)
To assess PK parameters of niclosamide injectable (DWRX2003) through t1/2(at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28)
To assess PK parameters of niclosamide injectable (DWRX2003) through Cmax(at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28)
To assess PK parameters of niclosamide injectable (DWRX2003) through AUC0-last(at Day 1, 2, 3, 5, 7, 10, 14, 21 and 28)